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Long-term Extension Study of Ligelizumab in Food Allergy

Primary Purpose

Food Allergy

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ligelizumab 120 mg
Ligelizumab 240 mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring Food allergy, oral food challenge, IgE, ligelizumab

Eligibility Criteria

6 Years - 57 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent and assent form (where applicable) Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy Participants are willing to adhere to the study visits and procedures, including receiving injections and participating in the oral food challenge Participants agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout the study Participants are able to safety continue into the study as judged by the investigator Exclusion Criteria: Development of a severe or life threatening episode of an allergic reaction that required intubation and/or Intensive Care Unit admission during the core studies Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core studies Development of uncontrolled asthma during the core study that could compromise the safety of participants judged by the investigator Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator Participants who failed to comply with the protocol requirements and procedures duringthe core study, and in the Investigator's opinion they should not participate in this extension study Platelets <75,000/ul at end of treatment of the core study Other protocol defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative SiteRecruiting
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  • Novartis Investigative Site
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  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ligelizumab 120 mg

Ligelizumab 240 mg

Arm Description

120 mg

240 mg

Outcomes

Primary Outcome Measures

Number of treatment-emergent AEs and SAEs
Long-term safety and tolerability of ligelizumab measured by incidence of Adverse Events and Serious Adverse Events An Adverse Event (AE) is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.

Secondary Outcome Measures

Number of participants tolerating a single dose of more than or equal to 600 mg of peanut protein without dose-limiting symptoms
Long-term efficacy of ligelizumab
Number of treatment emergent AEs and SAEs
Safety and tolerability of ligelizumab in all participants who administered study treatment at home by self-administration or parent/caregiver
Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) by age and responder
Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Questions are scored on a 7 point scale from 1 (no) to 7 (maximal) impairment on quality of life.
Scores in the Food Allergy Independent Measure (FAIM) by age and responder
Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Scores range from 1 (limited) to 7 (greatest) percieved food allergy severity and food allergy related risk.
Scores in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF36v2) by age and responder
Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. This 36 item instrument measures the impact of food allergy on social activities and depressions/nervousness.

Full Information

First Posted
January 9, 2023
Last Updated
October 23, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05678959
Brief Title
Long-term Extension Study of Ligelizumab in Food Allergy
Official Title
A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
October 28, 2030 (Anticipated)
Study Completion Date
February 17, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in particiants who have completed a ligelizumab Phase III study in food allergy.
Detailed Description
Participants will receive up to 3 years treatment with ligelizumab after which they will enter a follow-up period for 16 weeks. During the study, participants will undergo allergy testing by a Skin Prick Test and Oral Food challenge to test if the treatment is working or not. Accordingly, this study will generate data that should provide guidance relative to the long-term (chronic) use of ligelizumab in food allergic patients in terms of safety, efficacy, pharmaco-dynamics, biomarkers and Qualify of Life, and potential discontinuation from treatment. During the study, treatment will be administered every 4 weeks and while this can take place in the hospital clinic, some participants will be trained to administer study treatment at home by either the participant or parent/caregiver. Participants at home will record administration of the study treatment on a dosing log and return this to the clinic for review.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Food allergy, oral food challenge, IgE, ligelizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ligelizumab 120 mg
Arm Type
Experimental
Arm Description
120 mg
Arm Title
Ligelizumab 240 mg
Arm Type
Experimental
Arm Description
240 mg
Intervention Type
Drug
Intervention Name(s)
Ligelizumab 120 mg
Intervention Description
1 injection of 1.0 mL ligelizumab and 1 injection of 1.0 mL placebo
Intervention Type
Drug
Intervention Name(s)
Ligelizumab 240 mg
Intervention Description
2 injections of 1.0 mL ligelizumab
Primary Outcome Measure Information:
Title
Number of treatment-emergent AEs and SAEs
Description
Long-term safety and tolerability of ligelizumab measured by incidence of Adverse Events and Serious Adverse Events An Adverse Event (AE) is any untoward medical occurrence, unfavorable, or unintended sign (including an abnormal laboratory finding), symptom, disease, or injury, temporally associated with the use of a marketed or investigational medicinal product, gene therapy, theragnostic product, or medical device, in patients, clinical-trial subjects, device users, or other persons, whether or not it is considered to be related to or due to the product.
Time Frame
Up to 172 weeks
Secondary Outcome Measure Information:
Title
Number of participants tolerating a single dose of more than or equal to 600 mg of peanut protein without dose-limiting symptoms
Description
Long-term efficacy of ligelizumab
Time Frame
Day 1, Week 52, Week 104, Week 156
Title
Number of treatment emergent AEs and SAEs
Description
Safety and tolerability of ligelizumab in all participants who administered study treatment at home by self-administration or parent/caregiver
Time Frame
Up to 172 weeks
Title
Scores in the Food Allergy Quality of Life Questionnaire (FAQLQ) by age and responder
Description
Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Questions are scored on a 7 point scale from 1 (no) to 7 (maximal) impairment on quality of life.
Time Frame
Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156
Title
Scores in the Food Allergy Independent Measure (FAIM) by age and responder
Description
Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Scores range from 1 (limited) to 7 (greatest) percieved food allergy severity and food allergy related risk.
Time Frame
Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156
Title
Scores in the Medical Outcomes Study 36-item Short Form Version 2 Acute Version (SF36v2) by age and responder
Description
Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. This 36 item instrument measures the impact of food allergy on social activities and depressions/nervousness.
Time Frame
Day 1, 10 days before and 3 days after Week 52, 10 days before and 3 days after Week 104, 10 days before and 3 days after Week 156

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent and assent form (where applicable) Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy Participants are willing to adhere to the study visits and procedures, including receiving injections and participating in the oral food challenge Participants agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout the study Participants are able to safety continue into the study as judged by the investigator Exclusion Criteria: Development of a severe or life threatening episode of an allergic reaction that required intubation and/or Intensive Care Unit admission during the core studies Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core studies Development of uncontrolled asthma during the core study that could compromise the safety of participants judged by the investigator Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator Participants who failed to comply with the protocol requirements and procedures duringthe core study, and in the Investigator's opinion they should not participate in this extension study Platelets <75,000/ul at end of treatment of the core study Other protocol defined inclusion/exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0922
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Angers Cedex 1
ZIP/Postal Code
49033
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sagamihara-city
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

Long-term Extension Study of Ligelizumab in Food Allergy

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